Archives for November 8, 2018

A Balanced Scorecard

I am Dr. Jeff Kingsley and this is another edition of Riding in Cars With Researchers! Today we are continuing a series where we will talk about study site metrics. Specifically a balanced scorecard. A quick recap of what we discussed in prior episodes – a balanced scorecard is the sweet spot of KPIs (Key Performance Indicators). A site’s customers need something from you and I argue that they need EQTCS – Enrollment, Quality, Timelines, and Customer Service. Your balanced scorecard is the balancing point of the health of your research site with servicing the needs of your customers. I would argue that EQTCS needs to be in any site’s balanced scorecard.

Timelines

In the last episode, we discussed quality or the Q in EQTCS. Today we are going to talk about timelines. Our customers need us to move rapidly on everything. Our customers want us to be able to make rapid decisions on feasibility questionnaires, rapidly start-up a study, rapidly enroll the first patient in that study, quickly do query resolution, database lock. Our customers want responsiveness. Now, why do they want it? Just because it’s nice to have someone who is responsive to you? Sure it is, but it’s actually deeper than that. If you invent the cure for cancer today, you file your patent today. And your patent has a finite lifetime. You don’t wait until you actually know you discovered the cure for cancer before you file your patent. You filed your patent before you knew it was the cure for cancer. And that patent clock is ticking. It takes way too long to get through the R&D pipeline. It takes 15-20 years to complete research and submit that data to FDA for approval. And that length of time is eating away at patent life. That is one of the leading causes of why drugs cost what they do when they get their FDA approval. The owners of those compounds have to make back a massive investment before they even begin to turn a profit on all of those years of work. So they care about timelines – the faster you can move, the longer they have patent life, the cheaper they would come to market. I’ll say it again as many people don’t realize that sponsors don’t want to come to market at an expensive price. Trust me, they really don’t! If they come to market at an expensive price, they struggle more to get physicians to write for their medicine. Or if the physicians do write the prescription, there is a higher likelihood that insurance companies would deny payment, and won’t allow those patients to be on those drugs. It’s harder to get on formulary. So, the higher the price, the less they actually gain utilization of that drug in healthcare. If they can come to market more cheaply, more physicians would write for it, more patients would have it paid for, more insurance companies would allow it on formulary. So actually, if we can do R&D faster, drug prices will come down. It’s amazing and would be a wonderful thing. So think about it, if we could work faster, we serve our customers better, we speed innovation, we get new drugs to the patients that need them faster, and we reduce the cost of drugs when they get to market. All of that by moving more quickly.

Time is Easy to Measure

Time is easy to measure. So this is another important thing for sites to recognize. Our customers track time on us very easily. If you’re slow, your customers know it. They are tracking it, and it’s in their databases, and will impact study award at your sites. You’ve got to move faster because it matters and because it’s easy to measure.

Let’s talk about things you can do to move faster. Most of the time in what we do in clinical research is frankly wasteful. It doesn’t really take that length of time. On average in the U.S. it takes 26 weeks to do study start up – half a year! It’s not half a year’s worth of work. It’s a tiny fraction of that. And between a small piece of work, there is a long period of waiting. A long period where really no-one is doing anything. It’s sitting on someone else’s desktop to kick back to contract and budget. And then the recipient does a small amount of work, and kicks it back. And, again, it sits on someone else’s desktop. The same is true for pharmacy start up and lab start up, IRB approvals, and all of the other things that we do. Here’s something that you can do – don’t graph the length of time it takes to do study start up. Graph the actual length of time and actual activities performed. For example, if on average it takes you two months to do contract and budget negotiation, go talk to your contract and budget people. How long does it actually take them to do the first review of the contract and budget get back to the Sponsor? And then find out what the average length of time is before the Sponsor responds. That’s waste. Not entirely, but it’s largely waste. What if we could eliminate, or shave, just a few days from that interim period? All of those days cumulatively add up and make a huge difference.

Think about it and you will find all sorts of ways to shorten timelines in your research trials. If you shorten timelines, your customers will appreciate it, and you will help get new innovations to the patients who need it faster, and believe it or not, you will assist in reducing the cost of medicine when they come to market.

Thanks for riding along!

Send me topics you want me to talk about at connect@iact-health-staging.ycjrvwt5-liquidwebsites.com!